Brief Summary

The investigators are studying the use of Melatonin in non-ventilated patients over the age of 65. Primary endpoint will be assesments of delirium, with secondary endpoints to include length of stay, use of anti-psychotic medications, and mortality

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

600

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Dec 2016

Shorter than P25 for phase_4

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

December 1, 2016

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed

Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

January 3, 2017

Last Update Submit

July 10, 2017

Conditions

Delirium Melatonin

Outcome Measures

Primary Outcomes (1)

Delirium
Length of Hospital Stay, Average of 1 week

Secondary Outcomes (6)

Use of Antipsychotic Medications
Length of Hospital Stay, Average of 1 week
Average RASS Score
Length of Hospital Stay, Average of 1 week
ICU days
Length of Hospital Stay, Average of 1 week
Hospital Days
Length of Hospital Stay, Average of 1 week
30 day mortality
30 days post D/C
+1 more secondary outcomes

Study Arms (3)

Melatonin 5mg

ACTIVE COMPARATOR

This arm will be given 5mg tablets of Melatonin nightly for the duration of their hospital stay

Drug: Melatonin

Melatonin 3mg

ACTIVE COMPARATOR

This arm will be given 3mg tablets of Melatonin nightly for the duration of their hospital stay

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

This arm will be given a Sucrose tablet nightly for the duration of their hospital stay

Drug: Melatonin

Interventions

MelatoninDRUG

Patients will receive Melatonin at 2 different doses or a placebo

Melatonin 3mgMelatonin 5mgPlacebo

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersYes

Age GroupsOlder Adult (65+)

You may qualify if:

Non-ventilated Patients over the age of 65

You may not qualify if:

Patients with head trauma or Neurosurgical intervention
Patients \<65 years of age
Patients with an expected life expectancy \<48 hours
Blind patients
Patients with a seizure history
Patients with uncontrolled hypertension
Patients with a supratheraputic (\>3.0) INR
Patients on strong CYP1A2 inhibitors: ciprofloxacin, fluvoxamine, methoxsalen, ofloxacin, primaquine
Patients who do not speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MICE Trial Grouplead

Study Sites (1)

Parkview Medical Center

Pueblo, Colorado, 81003, United States

RECRUITING

Related Publications (10)

Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7. doi: 10.1164/rccm.200904-0537OC. Epub 2009 Sep 10.
PMID: 19745202BACKGROUND
Huang HW, Zheng BL, Jiang L, Lin ZT, Zhang GB, Shen L, Xi XM. Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment: which might be a more promising strategy for ICU sleep deprivation? Crit Care. 2015 Mar 19;19(1):124. doi: 10.1186/s13054-015-0842-8.
PMID: 25887528BACKGROUND
Chen S, Shi L, Liang F, Xu L, Desislava D, Wu Q, Zhang J. Exogenous Melatonin for Delirium Prevention: a Meta-analysis of Randomized Controlled Trials. Mol Neurobiol. 2016 Aug;53(6):4046-4053. doi: 10.1007/s12035-015-9350-8. Epub 2015 Jul 21.
PMID: 26189834BACKGROUND
Bourne RS, Mills GH. Melatonin: possible implications for the postoperative and critically ill patient. Intensive Care Med. 2006 Mar;32(3):371-9. doi: 10.1007/s00134-005-0061-x. Epub 2006 Feb 14.
PMID: 16477412BACKGROUND
Arendt J. In what circumstances is melatonin a useful sleep therapy? Consensus statement, WFSRS focus group, Dresden, November 1999. J Sleep Res. 2000 Dec;9(4):397-8. doi: 10.1111/j.1365-2869.2000.00229.x. No abstract available.
PMID: 11123525BACKGROUND
Artemiou P, Bily B, Bilecova-Rabajdova M, Sabol F, Torok P, Kolarcik P, Kolesar A. Melatonin treatment in the prevention of postoperative delirium in cardiac surgery patients. Kardiochir Torakochirurgia Pol. 2015 Jun;12(2):126-33. doi: 10.5114/kitp.2015.52853. Epub 2015 Jun 30.
PMID: 26336494BACKGROUND
Bellapart J, Boots R. Potential use of melatonin in sleep and delirium in the critically ill. Br J Anaesth. 2012 Apr;108(4):572-80. doi: 10.1093/bja/aes035.
PMID: 22419624BACKGROUND
Bourne RS, Mills GH, Minelli C. Melatonin therapy to improve nocturnal sleep in critically ill patients: encouraging results from a small randomised controlled trial. Crit Care. 2008;12(2):R52. doi: 10.1186/cc6871. Epub 2008 Apr 18.
PMID: 18423009BACKGROUND
Chakraborti D, Tampi DJ, Tampi RR. Melatonin and melatonin agonist for delirium in the elderly patients. Am J Alzheimers Dis Other Demen. 2015 Mar;30(2):119-29. doi: 10.1177/1533317514539379. Epub 2014 Jun 18.
PMID: 24946785BACKGROUND
Hatta K, Kishi Y, Wada K, Takeuchi T, Odawara T, Usui C, Nakamura H; DELIRIA-J Group. Preventive effects of ramelteon on delirium: a randomized placebo-controlled trial. JAMA Psychiatry. 2014 Apr;71(4):397-403. doi: 10.1001/jamapsychiatry.2013.3320.
PMID: 24554232BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Melatonin

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Mike Forte, DO

CONTACT

7195641542 mike_forte@parkviewmc.com

Josh Gordon, DO

CONTACT

7195641542 joshiah_gordon@parkviewmc.com

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, CARE PROVIDER
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 9, 2017

Study Start

December 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

Melatonin 5mg

Melatonin 3mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Locations